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Clinical Specialist

Berlin Heart Inc


Location:
Spring, Texas
Date:
08/30/2017
2017-08-302017-09-29
Job Status:
Full Time
Categories:
  • Clinical Operations
Berlin Heart Inc
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Job Details

POSITION PURPOSE The ideal candidate will work in a dynamic medical device research and development environment. This is a high visibility role with a significant and direct impact on the success of the company. Responsibilities will include providing clinical support for product range and assisting in the conduct of investigational clinical studies for Berlin Heart medical devices. This key position will be the primary interface between Berlin Heart and our customers in areas pertaining to clinical use and investigational studies. Additional responsibilities include ensuring investigational studies are conducted in compliance with U.S. laws and regulations in CFR Title 21 and the international Good Clinical practices (GCPs). The Clinical Specialist will be a key participant and contributor to the design of clinical trials.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

The duties of Clinical Specialist are to include but not limited to:

  • Provide on-site clinical support with pre-implant, peri-implant, and post-implant training and support at implanting centers throughout North America. A significant amount of overnight travel should be expected. * Perform patient follow-up and data collection related to outcomes, adverse events, and other patient related issues. * Support the EXCOR Pediatric IDE trial as required. * Establish clinical and business relationships with hospital staff across all levels. * Participate in sales and marketing activities as assigned within the limitations provided by the product approval status as granted by the FDA. * Provide twenty-four hour emergency telephone support on a rotational basis. * Assist implanting sights with maintaining regulatory compliance. * Prepare, modify and distribute study materials such as CRF’s, study reference manuals, and monitoring guidelines/manuals. * Assist in the development of research protocols, education materials, and scientific publications. * Actively communicate with clinical team members, including participation in team meetings and updates. * Participate in investigator meetings. * Establish in-house SOP’s as needed.

QUALIFICATIONS EDUCATION: BS with allied healthcare experience, Nurse Practitioner or Perfusioniest prefered.

REQUIRED KNOWLEDGE: Knowledge of Clinical Affairs documentation and design and implementation, demonstrated leadership skills, strong communication skills both written and spoken

EXPERIENCE: Minimum of 5 years direct work experience in medical device investigational clinical studies and associated experience with regulatory affairs.

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